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<h2>
    Human Subject.
</h2>
<p>
    The HHS regulations "Protection of Human Subjects" (45 CFR Part 46, administered
    by OHRP) define a human subject as a living individual about whom an investigator
    conducting research obtains: 
</p>
<ul>
    <li>Data through intervention or interaction with the individual or</li>
    <li>Identifiable private information</li>
</ul>
<p>
    <b>Investigator.</b>
    <br />
    The OHRP considers the term investigator to include anyone involved in conducting
    the research. OHRP does not consider the act of solely providing coded private information
    or specimens (for example, by a tissue repository) to constitute involvement in
    the conduct of the research. However, if the individuals who provide coded information
    or specimens also collaborate on other activities related to the conduct of the
    research with the investigators who receive such information or specimens, they
    will be considered to be involved in the conduct of the research (OHRP's Coded Specimen
    Guidance).
</p>
<p>
    <b>Research.</b> HHS regulations define research at 45 CFR 46.102(d) as follows:
    Research means a systematic investigation, including research development, testing
    and evaluation, designed to develop or contribute to generalizable knowledge. Activities
    which meet this definition constitute research for purposes of this policy, whether
    or not they are conducted or supported under a program which is considered research
    for other purposes. For example, some demonstration and service programs may include
    research activities.
</p>
<p>
    <b>Obtains.</b> In its guidance for use of coded specimens, OHRP has determined
    that under the definition of human subject at 45 CFR 46.102(f), obtaining identifiable
    private information or identifiable specimens for research purposes constitutes
    human subjects research. Obtaining means receiving or accessing identifiable private
    information or identifiable specimens for research purposes. OHRP interprets obtaining
    to include an investigator’s use, study, or analysis for research purposes of identifiable
    private information or identifiable specimens already in the possession of the investigator.
</p>
<p>
    <b>Intervention</b> includes both physical procedures by which data are gathered
    (for example, venipuncture) and manipulations of the subject or the subject's environment
    that are performed for research purposes (45 CFR 46.102(f)).
</p>
<p>
    <b>Interaction</b> includes communication or interpersonal contact between investigator
    and subject (45 CFR 46.102(f)).
</p>
<p>
    Private Information includes information about behavior that occurs in a context
    in which an individual can reasonably expect that no observation or recording is
    taking place, and information that has been provided for specific purposes by an
    individual and that the individual can reasonably expect will not be made public
    (for example, a medical record). Private information must be individually identifiable
    (i.e., the identity of the subject is or may readily be ascertained by the investigator
    or associated with the information) in order for obtaining the information to constitute
    research involving human subjects (45 CFR 46.102(f)).
</p>
<p>
    <b>Individually Identifiable Private Information.</b> According to its guidance
    for use of coded specimens, OHRP generally considers private information or specimens
    to be individually identifiable as defined at 45 CFR 46.102(f) when they can be
    linked to specific individuals by the investigator(s) either directly or indirectly
    through coding systems. Conversely, OHRP considers private information or specimens
    not to be individually identifiable when they cannot be linked to specific individuals
    by the investigator(s) either directly or indirectly through coding systems.
</p>
<p>
    <b>Coded.</b> With respect to private information or human biological specimens,
    coded means that:
</p>
<ul>
    <li>1. Identifying information (such as name or social security number) that would enable
        the investigator to readily ascertain the identity of the individual to whom the
        private information or specimens pertain has been replaced with a number, letter,
        symbol or combination thereof (i.e., the code); and </li>
    <li>2. A key to decipher the code exists, enabling linkage of the identifying information
        with the private information or specimens.</li>
</ul>
<p>
    Research that involves only coded private information/data or coded human biological
    specimens may not constitute human subjects research under the HHS human subjects
    regulations (45 CFR Part 46) if: 
</p>
<ul>
    <li>The specimens and/or information/data are not obtained from an interaction/intervention
        with the subject specifically for the research; and </li>
    <li>The investigator(s) cannot readily ascertain the identity of the individual(s) to
        whom the coded private information or specimens pertain (e.g., the researcher's
        access to subject identities is prohibited).</li>
</ul>
(See the following guidance from the Office for Human Research Protections (OHRP)
for additional information and examples: <a href="http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf">
    http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.pdf</a>.) 